Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3038185755

FEI Number

3038185755

Entity Name

DORMOTECH MEDICAL LTD.

City/State/Country

Afula Northern, IL

Establishment Address

Yitzhak rabin, Afula Northern 121, IL

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Dormotech Medical Ltd. (Owner Number: 10093114)

Owner / Operator Contact Address

Yitzhak rabin, Afula, IL-NOTA 121, IL

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K242290

PMA Number

N/A

All Registered Proprietary Names

Vlab DormoVision DormoTech NLab DormoVision

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GWL	Amplifier, Physiological Signal	Neurology	Class 2	882.1835	2025-04-01
MNR	Ventilatory Effort Recorder	Anesthesiology	Class 2	868.2375	2025-04-01
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2025-04-01
GWL	Amplifier, Physiological Signal	Neurology	Class 2	882.1835	2025-04-01
MNR	Ventilatory Effort Recorder	Anesthesiology	Class 2	868.2375	2025-04-01

Official Correspondent

Abed Nassir

US Agent Details

Matt Dryden Business: ProMedic, LLC Email: matt.dryden@promedic.cc Phone: (239) 3076063

Related Public Records

Same Entity

Dormotech Medical Ltd.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K082968	Apneicare, LLC	APNEICARE CONNECTION CENTER/INTERNET ANALYSIS	2009-01-02
K903523	Hewlett-Packard Co.	HP MODEL M1020A, ARTERIAL OXYGEN SAT/PLETH MODULE	1990-10-23
K973147	Nellcor Puritan Bennett, Inc.	NPB-295 PULSE OXIMETER	1997-11-14
K231243	Guangdong Genial Technology Co., Ltd.	Finger Clip Pulse Oximeter	2023-10-31
K971628	Somanetics Corp.	SOMANETICS INVOS 3100A CEREBRAL OXIMETER (INVOS)	1997-10-10

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0031-2022	NOX MEDICAL Keldnaholt Reykjavik Iceland	2	Nox T3s Recorder - Product Usage: intended for ambulatory recording of physiological signals during sleep.
Z-0020-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20 (US) N, Part Number CS08651
Z-0022-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20P (US) N - ROHS, Part Number CS08651-02
Z-0023-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20P (US) N - ROHS, Part Number CS08651-03
Z-0028-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	Capnostream20 (US) M, Part Number CS08653

Similar Registrations

Registration Number	Establishment Name	Location
3038274470	BRAINMATTERZ, INC	McKinney, TX, US
3015614098	CGX, LLC	San Diego, CA, US
3020018	CADWELL INDUSTRIES, INC.	KENNEWICK, WA, US
3010762896	NEUROELECTRICS BARCELONA S.L.U.	Barcelona Catalonia, ES
3005713796	G.TEC MEDICAL ENGINEERING GMBH	SCHIEDLBERG Oberosterreich, AT

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3038185755. Last updated year: 2026. Please use registration number 3038185755 when referencing this establishment in official correspondence.